Endothelial Cell Loss After Penetrating Keratoplasty

Phase 2

Completed

• Conditions: Keratoconus
• Interventions: Procedure: PKP

• Registration Number: NCT04457063
• Lead Sponsor: Alexandria University

Brief Summary

This work aimed at the assessment of corneal endothelial cell loss after toric ICL implantation for correction of myopia and astigmatism after penetrating keratoplasty.

Detailed Description

Penetrating keratoplasty (PKP) is considered a safe and effective procedure.This work aimed at the assessment of corneal endothelial cell loss after toric ICL implantation for correction of myopia and astigmatism after penetrating keratoplasty.

Study Timeline

• Study Start: 2018-07-01
• Status Verified: 2020-06
• Primary Completion: 2020-06-01
• Study Completion: 2020-06-15
• Study First Submitted: 2020-06-26
• Study First Submitted QC: 2020-06-30
• Last Update Submitted: 2020-06-30
• Study First Posted: 2020-07-07
• Last Update Posted: 2020-07-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

• PKP for keratoconus, and then toric ICL was implanted after minimum of one year with stable refraction

Exclusion Criteria

• Less than 18 and unable to give informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
penetrating keratoplasty	PKP	A prospective non-comparative non-randomized clinical study which was conducted on 12 eyes of 8 patients 4 males and 4 females who underwent PKP for keratoconus, and then toric ICL was implanted after minimum of one year with stable refraction

Primary Outcome Measures

Name	Time	Method
Refraction	1 year	Refractive measured by Diopter
Visual acuity	1 year	The decimal snellens
Intra-ocular pressure	1 year	mg

Trial Locations

Locations (1)

Alexandria Faculty of Medicine; 🇪🇬 Alexandria, Egypt